Measuring and testing – Sampler – sample handling – etc. – Sample holder
Reexamination Certificate
2001-06-11
2003-04-01
Noland, Thomas P. (Department: 2856)
Measuring and testing
Sampler, sample handling, etc.
Sample holder
C073S863210, C073S864410, C604S317000, C206S569000, C206S204000, C422S067000
Reexamination Certificate
active
06539817
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to an instrument for sampling and storing biological samples and particularly feces for use in biological or medical testing that may be easily and sanitarily packaged and sent via mail. More particularly, this invention relates to a disposable feces sampling and storage device that is inexpensive to produce and includes a desiccant to aid in drying a sample of feces that is stored therein.
In the field of medical care, lab tests that are performed on samples of body tissue, blood, urine, feces, etc., have become indispensable tools in aiding doctors with the diagnoses of the illnesses of their patients. With the continual development of new technology fueling the creation of new and improved lab equipment, new testing procedures are developed and old testing procedures are improved on an almost daily basis. While many of these tests necessarily require that blood be drawn or tissue be removed in order to perform the tests, it is generally desirable to use less invasive testing procedures whenever possible. Furthermore, some tests, such as the test for occult blood to verify the presence of gastrointestinal bleeding and tests for intestinal infections and parasites must be performed on fecal samples. Accordingly, testing procedures which use samples that can be collected using non-invasive procedures, such as urine and feces, have become increasingly popular among doctors and patients in recent years.
With the development of increased numbers of testing procedures which require the use of fecal samples, the demand for improved devices to sanitarily sample and transport these samples has correspondingly grown. In order to fill this need, there have been devices which have been designed for this purpose. For example, U.S. Pat. No. 5,149,506 to Skiba et al. discloses a stool collection and transport device which is composed of a vial having a sealable lid with an aperture formed therein for engaging a second lid. The second lid has a sampling spoon secured to the underside thereof so that a stool sample may be collected using the spoon and then sanitarily deposited in the collection vial.
While fecal sampling devices such as the one disclosed in the Skiba patent may be useful for collecting large samples which may then be sampled again using a smaller sampling device, these types of devices are generally not conducive to being sent through the mail. Furthermore, many of the latest fecal tests require that the samples collected be treated in some way shortly after collection in order to prevent degradation of the sample. For example, for some tests that are used to determine the presence of occult blood in a fecal sample, the sample must be stabilized in a liquid solution shortly after collection. This stabilization procedure is necessary to lessen the possibility that an inaccurate result is obtained from the test. Examples of sampling devices that are particularly useful for this type of test are disclosed in U.S. Pat. No. 5,514,341 to Urata et al. and U.S. Pat. No. 5,543,115 to Karakawa. Both of these patents disclose devices for collecting and storing fecal samples for use in testing procedures for the presence of occult blood. In order to use these devices, the sample is collected on the end of a sampling rod which is then inserted into a storage container having a fixed amount of stabilizing solution, such as glycosidase-type bacteriolytic enzyme, contained therein. Then, the container is sealed and the sample is allowed to mix with the stabilizing solution. Finally, when the sample is ready for testing, the stabilized liquid is passed through a filter which is preferably secured in the container. The testing procedure is then run on the filtrate.
While the devices disclosed in these patents are useful for testing procedures that determine the presence of occult blood and require that the sample be stabilized shortly after collection as described above, there are other testing procedures for which these types of devices are not particularly well-suited. For example, in some testing procedures, such as the occult blood assays that detect labile exoantigens and cell associated antigens of
C. difficile, E. coli
, it is preferred that the sample be as dry as possible. Thus, the presence of a stabilization liquid, or any liquid at all for that matter, is considered undesirable. Furthermore, since liquid is not used in the stabilization procedure, the use of a filter and dropper assembly as disclosed in the Urata patent is unnecessary.
Accordingly, it would be desirable to have a feces sampling and storage container that can be used for easily collecting and storing feces samples that need to be maintained in a relatively dry atmosphere. Preferably, the container would be small and self contained so that it would be easy and inexpensive to transport or mail and would include a device or substance for aiding in the drying of the sample, such as a desiccant. Preferably, the container would be inexpensive to produce so that it would be disposable and would be simple to use so that a patient or untrained individual could easily use the device to collect a sample with little or no instruction.
SUMMARY OF THE INVENTION
In accordance with the present invention, a feces sampling and storage container is provided which is comprised of a generally hollow body and a sampling wand shaped to frictionally or threadably engage and plug one end of the body. The sampling wand is relatively long and has a sampling tip positioned at its distal end that is designed to collect a sample of at least a minimum size when the sampling wand is inserted into a feces sample and removed. In a preferred embodiment, the sampling tip of the wand is formed in a broad tipped “spatula” shape having grooves and protrusions formed thereon. Thus, when the sampling tip is inserted into a mass of feces, an adequate amount of sample is collected in the grooves and on the tip.
Preferably, the body of the container is tubular in shape and has at least two chambers. The container does not include a liquid for interaction with a sample contained therein. One of the chambers, the sampling chamber, is designed to receive the sampling wand. The other chamber, the drying chamber, is designed to hold a drying device, such as a desiccant. The drying chamber is maintained in gaseous communication with the sampling chamber by a gas permeable barrier so that water vapor from the sample may be drawn away from the sample to the desiccant. Preferably a screen or other device, such as a constriction in the body, a wad of cotton or a gas permeable membrane, is used to hold the desiccant in the drying chamber and away from direct contact with the sample. This is desired because direct contact between the desiccant and the sample could contaminate the sample causing inaccurate test results. Furthermore, the desiccant could become fouled thereby affecting its ability to remove water from the sample as desired.
In a preferred embodiment, the sampling wand includes a stopper end which is constructed to be frictionally received and held in a mouth of the body. The stopper seals the container preventing water vapor from getting into the container once the sample is collected while simultaneously preventing any of the sample from leaking out. This is important because the integrity of the container must be maintained during shipping and handling due to sanitary concerns. Furthermore, this prevents contamination of the sample from outside contaminants, helping to insure that the tests performed on samples retrieved and stored using the sampling and storage container of the present invention yield results which are as accurate as possible. Additionally, in a preferred embodiment, a thumb tab is formed on the top of the stopper to assist a user in the insertion and removal of the wand from the body, as well as in the sanitary collection of a sample.
Preferably the sampling and storage container of the present invention is made from a lightweight inexpensive plastic, such as polyethylene, which is l
Kozak Kenneth James
Yi Ching Sui Arthur
Frost Brown Todd LLC
Meridian Bioscience, Inc.
Noland Thomas P.
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